Piloting the draft National Clinical Trials Governance Framework

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Feedback is sought on the draft National Clinical Trials Governance Framework (Governance Framework) that has been finalised by the Australian Commission on Safety and Quality in Health Care (the Commission).

The Commission is seeking feedback on the Governance Framework’s supporting tools and resources, and for expressions of interest from health service organisations to participate as one of 12 pilot sites. Both avenues of feedback will be undertaken from March to May 2020.

The Governance Framework aims to improve quality, efficiency and timeliness of clinical trials by reducing duplication and increasing efficiency, cohesion and productivity across the clinical trials sector.

AusBiotech has engaged with the Commission throughout the consultation process, including workshops held in February 2019. Following this national consultation, Australian Health Ministers agreed in November 2019 for the Commission to undertake the pilot in health service organisations that are currently accredited to the National Safety and Quality Health Service (NSQHS) Standards that conduct clinical trials.

The purpose of this feedback is to ensure:

  • health service organisations conducting clinical trials understand the intent of the Governance Framework (Standards 1 and 2);
  • the Governance Framework enables health service organisations to identify and address gaps in safety and quality of clinical trial service provision;
  • the structure, sequence and format of the Governance Framework is logical and easily understood;
  • the language on the intent of the Governance Framework is specific and clear;
  • the Governance Framework can be implemented by health service organisations providing clinical trials and assessed for compliance to the actions within NSQHS Standards 1 and 2; and,
  • identification of additional resources that may be required to support national implementation of the Governance Framework.

Read more information on the National Clinical Trials Governance Framework, including the literature review and mapping exercise report, on the Commission’s website.

Expressions of interest must be lodged no later than 13 March 2020. Register your interest in providing feedback on the supporting tools and resources (Level 1) or participating as one of the 12 pilot sites (Level 2). Successful applicants will be notified by the Commission.